FDA.reportPublic FDA data

Anti Allergy

Product NDC
54738-103
Requested package NDC
54738-103-01
11-digit product format
547380103
Labeler code
54738
Product ID
54738-103_5cc3ebfe-ce74-423d-e053-2a91aa0a4616
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Richmond Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-05-01
Substance
CHLORPHENIRAMINE MALEATE
Active strength
4 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anti Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1363309Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
316db99f-5a13-48e0-9a6b-ab7a76fe4d28Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-103-01Anti Allergy100 in 1 BOTTLETABLET1002
54738-103-03Anti Allergy1000 in 1 BOTTLETABLET10002
54738-103-14Anti Allergy24 in 1 BOTTLETABLET242

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-103-01EA - Each54738-1033ba3deb0-2c3a-4c8a-aa9f-4fbfca573a3e12017-11-06
54738-103-03EA - Each54738-10308895da8-8ff1-40c0-8d86-2123a788d39412017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-103ANTI ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20171030_316db99f-5a13-48e0-9a6b-ab7a76fe4d28.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti AllergyCHLORPHENIRAMINE MALEATERichmond Pharmaceuticals, Inc.316db99f-5a13-48e0-9a6b-ab7a76fe4d282017-10-30WarningsExact identifier
ndc (package): 54738-103-01
ndc (product): 54738-103
ndc11 (package): 54738010301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN316db99f-5a13-48e0-9a6b-ab7a76fe4d282
1363309chlorpheniramine maleate 4 MG Oral TabletSCD316db99f-5a13-48e0-9a6b-ab7a76fe4d282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54738-103-0154738010301100 TABLET in 1 BOTTLE (54738-103-01) 100 tablet2015-05-010000-00-00NoNoCurrent